Formulary
Stiripentol: Indications, Dosing, Side Effects and Interactions
Stiripentol clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 3 min read
Stiripentol: Indications, Dosing, Side Effects and Interactions
Stiripentol clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Adjunctive therapy of refractory generalised tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (Dravet syndrome) in combination with clobazam and valproate (under expert supervision)**
- **Adult** (By Mouth): Doses of up to 50 mg/kg daily in 2-3 divided doses should be continued for as long as efficacy is observed.
**Adjunctive therapy of refractory generalised tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (Dravet syndrome) in combination with clobazam and valproate (under expert supervision) for stiripentol**
- **Child 1 month-5 years** (By mouth): Initially 20 mg/kg daily in 2-3 divided doses for 1 week, then increased to 30 mg/kg daily in 2-3 divided doses for 1 week, then increased to 50 mg/kg daily in 2-3 divided doses.
- **Child 6-11 years** (By mouth): Initially 20 mg/kg daily in 2-3 divided doses for 1 week, then increased in steps of 10 mg/kg daily in 2-3 divided doses, dose to be increased at intervals of 1 week to 50 mg/kg daily in 2-3 divided doses.
- **Child 12-17 years** (By mouth): Initially 20 mg/kg daily in 2-3 divided doses for 1 week, then increased to 30 mg/kg daily in 2-3 divided doses for 1 week, then increased in steps of 5 mg/kg daily in 2-3 divided doses, dose to be increased at intervals of 1 week, until the optimum dose is reached based on clinical judgement; maximum 50 mg/kg per day.
Contraindications
History of psychosis in the form of episodes of delirium
Side effects
Common or very common Agitation; appetite decreased; behaviour abnormal; drowsiness; irritability; movement disorders; muscle tone decreased; nausea; neutropenia; sleep disorders; vomiting; weight decreased Uncommon Diplopia; fatigue; photosensitivity reaction; skin reactions Rare or very rare Thrombocytopenia Frequency not known Suicidal behaviours
Interactions
**Severe interactions:**
- At therapeutic concentrations, stiripentol significantly inhibits several CYP450 isoenzymes: for example, CYP2C19, CYP2B6 and CYP3A4.
- This warning is not only restricted to medicinal products but also to a considerable number of foods (for example: cola, chocolate, coffee, tea, and energy drinks) and nutritional products aimed at...
**Other interactions (16):**
- Potential medicinal product interactions affecting stiripentol The influence of other antiepileptic medicinal products on stiripentol pharmacokinetics is not well established.
- The impact of macrolides and azole antifungal medicinal product on stiripentol metabolism, that are known to be inhibitors of CYP3A4 and substrates of the same enzyme, is not known.
- Likewise, the effect of stiripentol on their metabolism is not known.
- In vitro studies suggested that stiripentol phase 1 metabolism is catalyzed by CYP1A2, CYP2C19 and CYP3A4 and possibly other enzymes.
- Caution is advised when combining stiripentol with other substances that inhibit or induce one or more of these enzymes.
- Effect of stiripentol on cytochrome P450 enzymes Many of these interactions have been partially confirmed by in vitro studies and in clinical trials.
Pregnancy
Important safety information For stiripentol MHRA/CHM advice: Antiepileptics: risk of suicidal thoughts and behaviour (August 2008) See Epilepsy . MHRA/CHM advice: Antiepileptic drugs: updated advice on switching between different manufacturers' products (November 2017) See Epilepsy . MHRA/CHM advice: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review (January 2021) See Epilepsy .
Breast feeding
Present in milk in animal studies.
Hepatic impairment
Manufacturer advises avoid (no information available).
Renal impairment
Avoid-no information available. M
Medicinal forms
Capsule,Suspension
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
Inside MedNext for this topic
- 411 MedNext-authored chapters
- 80,000+ MCQ bank
- 15 study modes
- Growing visual cheat sheets
Study modes
- Notes
- MCQ
- Audio
- Video
- Visual
- 3D Anatomy
- Trace
- Flashcards
- Mnemonics
- Image Bank
- Clinical
- Microscopy
- Audio QBank
- Cadaver
- Book Match
Continue reading
Subject HubPharmacology Hub
All pharmacology resources in one place.
Drug SchedulesIndian Drug Schedules
Schedule H, H1, X and G classifications.
FormularyBrowse all drugs
Search 1,850+ drug profiles.
Study Stiripentol in the MedNext app
Challenge yourself with targeted pharmacology MCQs on this drug class. Every explanation links back to the chapter that teaches the concept.
Start drug challengeExplore the full formulary

